Today, Allergan plc (NYSE:AGN) announces the launch of Ozurdex® (dexamethasone intravitreal implant 0.7 mg) in China for the treatment of adult patients with macular edema secondary to retinal vein occlusion (RVO). RVO is the second most common type of retinal vascular disorder after diabetic retinal diseaseiv and it is estimated that 7.4 million people in China are living with the condition.i,ii,iii
RVO is caused by blockages in the central retinal vein (CRVO) or in the surrounding branch retinal veins (BRVO) which leads to disrupted blood flow, haemorraghing and eventually macular edema.v If left untreated, RVO can result in sudden and painless loss of vision.vi Symptoms of the disease include blurry vision and floaters (dark spots and lines in vision).vii, viii
Ozurdex® is the first approved intravitreal injection for RVO in China and is licensed for the treatment of macular edema following BRVO and CRVO. Allergan has accelerated access to this treatment in 27 hospitals across China, making it available as a first-line treatment for this potentially sight-threatening condition. Ozurdex® was put on the priority approval list by the Chinese Food and Drug Administration (CFDA) and was granted an Imported Drugs Licence (IDL) in October 2017.
Dr. Dai Hong, Director of Ophthalmology at Beijing Hospital comments, "RVO is a devastating condition that affects millions of patients in China. It can lead to macular edema, the thickening of the macular region in the eye, and if left untreated results in poor vision. Macular edema is the leading cause of visual impairment in RVO. Being able to offer these patients a proven treatment option allows ophthalmologists to consider a more tailored management approach, helping to reduce the treatment burden for patients and alleviate pressure on local eye care services."
Ozurdex® is a biodegradable implant containing the anti-inflammatory corticosteroid, dexamethasone. It is implanted in the back of the eye, via a single use applicator, and the implant slowly releases dexamethasone directly to the retina over a period of several months.ix Inflammation plays a role in the development of RVO and is a critical component in macular edema.x This treatment works by suppressing inflammatory mediators and delivers sustained visual gains.xi
"Providing millions of RVO patients access to Ozurdex® is a significant step towards preventing blindness and meeting a critical unmet need in China," comments Marc Princen, Allergan International President. "As the global prevalence of eye diseases grows, Allergan remains committed to reducing this burden and delivering innovative treatments to people most in need around the world."
About retinal vein occlusion (RVO)?
Retinal vein occlusion is the second most common cause of reduced vision due to a retinal vascular disorder; the most common cause is diabetic retinopathy.i It is defined as obstruction of a retinal vein, which causes haemorrhage in the retina. This process eventually leads to macular edema, i.e. thickening of the macular region. Left untreated, macular edema can result in decreased visual acuity.iv
Retinal vein occlusion occurs when the circulation of the retinal vein becomes blocked by an adjacent blood vessel or thrombosis. It can be classified according to the location of the occlusion. BRVO occurs in a branch retinal vein and CRVO occurs in the central retinal vein and involves all four quadrants of the retina. BRVO and CRVO have distinct underlying causes, prognoses and outcomes, and commonly require different management strategies.iv
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye ...
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